Drug Delivery Device for the Treatment of Patients with Respiratory Diseases

1. A therapeutic method of treating a patient with at least one respiratory disease, said therapeutic method comprising: providing a dry powder inhaler having therein a powdered medicament with a formulation comprising (1) a beta- 2 agonist, an anti-cholinergic, or a corticosteroid alone or in any combination thereof, and (2) coarse carrier particles of a physiologically acceptable excipient having a mass median diameter higher than 90 microns and a mass diameter between 50 microns and 500 microns; and administering the powdered medicament using the dry powder inhaler, wherein the dry powder inhaler includes: a body, and a cover, wherein the body of the dry powder inhaler has: a container including a medicament chamber for storing the powdered medicament and an integral desiccant chamber for storing a desiccant, the desiccant chamber being separated from the medicament chamber by a permeable membrane, a metering member having a dosing recess, the metering member being moveable between a filling position, in which the dosing recess is in alignment with an opening of the container so as to be filled with a dose of the powdered medicament, and an inhalation position, in which the dosing recess is in alignment with an inhalation channel, a mouthpiece in communication with the inhalation channel to enable inhalation of the dose of the powdered medicament contained in the dosing recess of the metering member when the metering member is in the inhalation position, a protective member, provided between the metering member and the inhalation channel, that is moveable between a closed position, in which the protective member at least covers the dosing recess of the metering member when the metering member is in the inhalation position, thereby preventing the powdered medicament contained in the dosing recess from entering into the inhalation channel and an open position, in which the protective member does not cover the dosing recess, thereby exposing the dosing recess to the inhalation channel so as to enable inhalation of the dose of the powdered medicament contained in the dosing recess, a breath actuated mechanism (BAM) coupled to the protective member such that, when the protective member is in the closed position, the BAM causes the protective member to move into the open position responsive to an inhalation suction force effected by the patient exceeds a predetermined value, and the inhalation channel, provided with a deagglomerator system to deagglomerate the powdered medicament, the inhalation channel having a vortex chamber with an opening for the supply of the powdered medicament, two air inlets to direct air tangentially into the vortex chamber, and an outlet to output air with the deagglomerated powdered medicament, the outlet being spaced from the air inlets in an axial direction of the deagglomerator system, an outer wall of each air inlet being connected to the other air inlet by an arched wall portion of the vortex chamber, and each arched wall portion being positioned non-concentric to a horizontal circle defining a diameter of the vortex chamber of 6 mm<d<10 mm, where ‘d’ is the diameter, wherein the dry powder inhaler further includes: a microphone integrated with a preamplifier mounted on an external surface of the body of the dry powder inhaler, and processing circuitry configured to: process an acoustic signal, produced in correspondence with airflow through the deagglomerator system, obtained from the microphone, determine one or more operating conditions of the dry powder inhaler, for use for treatment of the patient affected by the at least one respiratory disease, based on the processed acoustic signal, (i) track the acoustic signal obtained from the microphone during an inhalation of the patient, (ii) convert the acoustic signal into a flow inhalation profile using stored first calibration data, (ii) process the acoustic signal obtained from the microphone to detect firing of the BAM and a timing of delivery of the powdered medicament during the inhalation of the patient, (iv) compare the detected timing of the delivery of the powdered medicament relative to the flow inhalation profile with stored second calibration data to determine whether the delivery of the powdered medicament meets a desired delivery condition, enable monitoring, based on (i)(iv), of: (a) a flow rate profile, (b) that the BAM did not fire, (c) that the BAM fired but nothing was delivered, and (d) that the BAM fired and the powdered medicament was delivered, wherein the patient is a child younger than 12 years old, and wherein the at least one respiratory disease includes moderate to severe persistent asthma or severe chronic obstructive pulmonary disease (COPD).

2. The therapeutic method according to claim 1 , wherein the cover of the dry powder inhaler is rotatably coupled to the body so that the cover is moveable between a closed position, in which the cover covers the mouthpiece, and an open position, in which the cover exposes the mouthpiece.

3. The therapeutic method according to claim 2 , wherein the formulation comprises formoterol fumarate dihydrate and beclometasone dipropionate.

4. The therapeutic method according to claim 2 , wherein the body of the dry powder inhaler has a window to display a number of doses of the powdered medicament remaining in the container or having been inhaled, the number of doses of the powdered medicament being counted by a dose counting unit.

5. The therapeutic method according to claim 4 , wherein the formulation comprises formoterol fumarate dihydrate and beclometasone dipropionate.

6. The therapeutic method according to claim 2 , wherein the body of the dry powder inhaler has an opening to display a mark showing whether the dose of the powdered medicament contained in the dosing recess of the metering member is ready for inhalation, or has already been inhaled.

7. The therapeutic method according to claim 6 , wherein the formulation comprises formoterol fumarate dihydrate and beclometasone dipropionate.

8. The therapeutic method according to claim 1 , wherein the one or more operating conditions of the dry powder inhaler comprise one or more of an inspiratory flow rate by time, a flow at and time to BAM activation, a peak inspiratory flow (PIF) and time to PIF, an initial acceleration, and a total inhaled air volume.

9. The therapeutic method according to claim 1 , wherein the processing circuitry is mounted within the body of the dry powder inhaler.

10. The therapeutic method according to claim 1 , wherein the formulation comprises formoterol fumarate dihydrate and beclometasone dipropionate.

11. The therapeutic method according to claim 1 , wherein the microphone is a MicroElectrical-Mechanical System (MEMS) microphone.

12. The therapeutic method according to claim 1 , wherein the microphone is mounted on a bottom of the external surface of the body of the inhaler.

13. The therapeutic method according to claim 1 , further comprising outputting, from the dry powder inhaler, to the processing circuitry, data corresponding to the acoustic signal obtained from the microphone, the processing circuitry processing the data to determine the one or more operating conditions of the dry powder inhaler, for use for treatment of the patient affected by the moderate to severe persistent asthma or the severe COPD, wherein the processing circuitry is remote from the dry powder inhaler.

14. The therapeutic method according to claim 1 , further comprising storing, in memory, a count corresponding to a number of times that the BAM is activated and the deagglomerated powdered medicament is successfully delivered, and a second count corresponding to a number of times that the BAM is activated but no deagglomerated powdered medicament is delivered or a suitable amount of the deagglomerated powdered medicament is not delivered, based on data corresponding to each said acoustic signal obtained from the microphone and processed by the processing circuitry.

15. A therapeutic method of treating a patient with at least one respiratory disease, said therapeutic method comprising: providing a dry powder inhaler having therein a powdered medicament with a formulation comprising (1) a beta- 2 agonist, an anti-cholinergic, or a corticosteroid alone or in any combination thereof, and (2) coarse carrier particles of a physiologically acceptable excipient having a mass median diameter higher than 90 microns and a mass diameter between 50 microns and 500 microns; administering the powdered medicament using the dry powder inhaler, wherein the dry powder inhaler includes: a body, and a cover, wherein the body of the dry powder inhaler has: a container including a medicament chamber for storing the powdered medicament and an integral desiccant chamber for storing a desiccant, the desiccant chamber being separated from the medicament chamber by a permeable membrane, a metering member having a dosing recess, the metering member being moveable between a filling position, in which the dosing recess is in alignment with an opening of the container so as to be filled with a dose of the powdered medicament, and an inhalation position, in which the dosing recess is in alignment with an inhalation channel, a mouthpiece in communication with the inhalation channel to enable inhalation of the dose of the powdered medicament contained in the dosing recess of the metering member when the metering member is in the inhalation position, a protective member, provided between the metering member and the inhalation channel, that is moveable between a closed position, in which the protective member at least covers the dosing recess of the metering member when the metering member is in the inhalation position, thereby preventing the powdered medicament contained in the dosing recess from entering into the inhalation channel and an open position, in which the protective member does not cover the dosing recess, thereby exposing the dosing recess to the inhalation channel so as to enable inhalation of the dose of the powdered medicament contained in the dosing recess, a breath actuated mechanism (BAM) coupled to the protective member such that, when the protective member is in the closed position, the BAM causes the protective member to move into the open position responsive to an inhalation suction force effected by the patient exceeds a predetermined value, and the inhalation channel, provided with a deagglomerator system to deagglomerate the powdered medicament, the inhalation channel having a vortex chamber with an opening for the supply of the powdered medicament, two air inlets to direct air tangentially into the vortex chamber, and an outlet to output air with the deagglomerated powdered medicament, the outlet being spaced from the air inlets in an axial direction of the deagglomerator system, an outer wall of each air inlet being connected to the other air inlet by an arched wall portion of the vortex chamber, and each arched wall portion being positioned non-concentric to a horizontal circle defining a diameter of the vortex chamber of 6 mm<d<10 mm, where ‘d’ is the diameter, wherein the dry powder inhaler further includes: a microphone integrated with a preamplifier mounted on an external surface of the body of the dry powder inhaler, and processing circuitry operable to process an acoustic signal produced in correspondence with airflow through the deagglomerator system, obtained from the microphone, to determine one or more operating conditions of the dry powder inhaler, for use for treatment of the patient affected by the at least one respiratory disease, wherein the at least one respiratory disease includes moderate to severe persistent asthma or severe chronic obstructive pulmonary disease (COPD), and wherein the formulation comprises formoterol fumarate dihydrate and beclometasone dipropionate; outputting, from the dry powder inhaler, to the processing circuitry, data corresponding to the acoustic signal, wherein the processing circuitry is remote from the dry powder inhaler; processing, using the processing circuitry, the acoustic signal; determining, using the processing circuitry, the one or more operating conditions of the dry powder inhaler, for use for treatment of the patient affected by the moderate to severe persistent asthma or the severe COPD based on the processed acoustic signal; (i) tracking, using the processing circuitry, the acoustic signal obtained from the microphone during an inhalation of the patient, (ii) converting, using the processing circuitry, the acoustic signal into a flow inhalation profile using stored first calibration data, (ii) processing, using the processing circuitry, the acoustic signal obtained from the microphone to detect firing of the BAM and a timing of delivery of the powdered medicament during the inhalation of the patient, (iv) comparing, using the processing circuitry, the detected timing of the delivery of the powdered medicament relative to the flow inhalation profile with stored second calibration data to determine whether the delivery of the powdered medicament meets a desired delivery condition, monitoring, using the processing circuitry and based on (i)-(iv): (a) a flow rate profile, (b) that the BAM did not fire, (c) that the BAM fired but nothing was delivered, and (d) that the BAM fired and the powdered medicament was delivered.